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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02168634
Other study ID # VGHKS13-CT12-23
Secondary ID
Status Recruiting
Phase N/A
First received March 11, 2014
Last updated October 7, 2015
Start date November 2013

Study information

Verified date October 2015
Source Kaohsiung Veterans General Hospital.
Contact Kuei-Chang Hsu, MD
Phone 886975581795
Email kchsu@vghks.gov.tw
Is FDA regulated No
Health authority Taiwan : Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Hypertrophic scar, a disfiguring tissue reaction to trauma, occurred in around 20 % of the population. The patients with hypertrophic scar usually seek medical assistance not just for the annoying appearance but mostly due to the intractable itchiness. There have been a variety of effective methods to alter the appearance of the scar. However, the treatments for itching from hypertrophic scar are scarce. In 2009, P.Gazerani used Botox to treat histamine-induced itch with favorable results. In the clinical setting, however, the efficacy of Botox to treat itch from hypertrophic scar was yet to be proven. Therefore, the goal of this study is to conduct a randomized controlled trials about using Botox to treat itch from hypertrophic scar.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. The patients undergoing laparotomy and thoracotomy in Veterans General Hospital in Kaohsiung (VGHKS) during 2003/1/1~2012/12/31

2. Hypertrophic scars containing more than two itchy sites with itchiness scale >3

3. Good wound healing condition, no infection sign

4. Age older than 20 year-old

Exclusion Criteria:

1. Allergy to Botulinum toxin

2. Inability to express self-willingness

3. Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Botulinum Toxins
5U botulinum toxin in 1c.c. normal saline, local injection
Placebo
1cc normal saline, local injection

Locations

Country Name City State
Taiwan Kaohsiung Veterans General Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Akhtar N, Brooks P. The use of botulinum toxin in the management of burns itching: preliminary results. Burns. 2012 Dec;38(8):1119-23. doi: 10.1016/j.burns.2012.05.014. Epub 2012 Jul 12. — View Citation

Gazerani P, Pedersen NS, Drewes AM, Arendt-Nielsen L. Botulinum toxin type A reduces histamine-induced itch and vasomotor responses in human skin. Br J Dermatol. 2009 Oct;161(4):737-45. doi: 10.1111/j.1365-2133.2009.09305.x. Epub 2009 May 11. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The degree of itchiness 6 months No
Secondary Pain scale We'll ask the participant about the pain during injection. The question will be asked within one minute after drug injection. Within one minue after drug injection No
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